Pre-Review

All submissions are first reviewed by an IRB Analyst in the HRPP Office. If there are missing documents or if further information is required that is necessary for the IRB to make appropriate decisions, the IRB Analyst will contact the Principal Investigator (PI) and/or Research Coordinator. Changes will be made to the eIRB application in a collaborative approach between the HRPPO staff and research team.

This process ends once the file is complete and “IRB Ready.” At that time, the submission will either be sent to an Expedited Reviewer (for Exempt and Expedited studies) or added to a Full Board agenda (studies not meeting exempt/expedited criteria).

IRB Review

After Review by the Expedited Reviewer or Full Board, a letter will be sent with the review decision. You must respond promptly to any stipulations or deferral notes. If the study is pending a response to stipulations or a deferral for more than 30 days without a response, the IRB may close the study (studies approved with stipulations) or withdraw the application (deferred studies). If this occurs, you will be required to restart the application process.

Types of Reviews

Exempt & Expedited Review

Review of proposed research by an Expedited Reviewer (IRB Chair or designated voting member) rather than by the entire IRB. Federal rules permit exempt and expedited review for certain kinds of research. Note: Investigators cannot “self-exempt” research protocols that meet the exempt criteria.

Full-Board Review

Review of proposed research at a convened meeting where a majority of IRB members are present.